Alternative Surveillance Program for Patients With High Risk Group of HCC
1 other identifier
interventional
199
1 country
1
Brief Summary
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Jan 2023
Typical duration for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedStudy Start
First participant enrolled
January 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 15, 2025
May 1, 2025
3.1 years
December 10, 2022
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
up to one year
Secondary Outcomes (4)
Comparison of annual focused MRI and biannual US for HCC detection
up to one year
diagnostic yield for HCC
up to one year
scan time of focused MRI
up to one month
comparison between false referral rates of biannual US and annual focused MRI
up to one year
Other Outcomes (1)
comparison between incidental findings between biannual US and annual focused MRI
up to one year
Study Arms (1)
US & MRI
EXPERIMENTALAll participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.
Interventions
non-contrast liver MRI focusing on HCC surveillance in a short scan time.
Eligibility Criteria
You may qualify if:
- chronic hepatitis B or C
- Child-Pugh classification A
- HCC risk score \>= -2.04
- have not diagnosed with HCC
- on surveillance program using US and negative on previous US within 6-8 months of enrollment
- sign informed consent
You may not qualify if:
- younger than 40 years or older than 70 years old
- history of HCC
- severe GFR or on HD/PD due to renal failure
- contra-indication of MRI
- congestive hepatopathy
- iron deposition
- pregnancy or nursing mother
- non-viral hepatitis or liver cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Severance Hospitalcollaborator
- The Catholic University of Koreacollaborator
- Korea University Guro Hospitalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Hee Yoon, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 10, 2022
First Posted
December 20, 2022
Study Start
January 6, 2023
Primary Completion
February 28, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share